Confocal Laser Endomicroscopy in Digestive Diseases
1 other identifier
observational
500
1 country
1
Brief Summary
Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared with other device such as Narrow Band Imaging and Autofluoresecence Imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 23, 2010
July 1, 2010
1.3 years
June 29, 2010
November 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic yield for neoplasia of CLE vs. standard endoscopy
one year
Secondary Outcomes (1)
Diagnostic yield for neoplasia of CLE vs. NBI/AFI
one year
Study Arms (2)
Case (subjects with digestive diseases)
The investigators cases are subjects with confirmed digestive diseases.
Control
Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases.
Interventions
Confocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure.
NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.
Eligibility Criteria
Patients of a tertiary referral hospital
You may qualify if:
- Subjects over 18 years of age
- Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included
You may not qualify if:
- Under 18 years of age.
- Pregnancy or breast feeding
- Allergy to the fluorescent contrast agent fluorescein sodium
- Coagulopathy or bleeding disorder
- In emergency or life-threatening situations(eg. acute gastrointestinal hemorrhage, and gastrointestinal obstruction or perforation)
- impaired renal function, allergic asthma,
- Cognitively impaired.
- Residing in institutions (eg. prison, extended care facility)
- Have language barriers (eg. illiterate, dysphasic)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China PLA General Hospital
Beijing, Bejing, 100853, China
Related Publications (1)
Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
PMID: 26078575DERIVED
Biospecimen
biopsy tissue
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yunsheng Yang, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 2, 2010
Study Start
August 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2011
Last Updated
November 23, 2010
Record last verified: 2010-07